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Clinical Study to Assess Efficacy and Safety of a New Compression System in the Management of Venous Leg Ulcers

NCT02782689 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2018-04-26

No results posted yet for this study

Summary

The primary objective of this study is to demonstrate the non-inferiority of the 2-layer compression system Kit Biflex® with regard of the 4-layer compression system PROFORE® in the treatment of venous leg ulcers in terms of complete healing at 16 weeks.

Conditions

  • Venous Leg Ulcer

Interventions

DEVICE

Kit Biflex

Two-layer reusable compression system

DEVICE

Profore

Four-layer compression system

Sponsors & Collaborators

  • Thuasne

    lead INDUSTRY

Principal Investigators

  • Jean-Luc GILLET, MD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2016-12-31
Completion
2017-03-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02782689 on ClinicalTrials.gov